vx 661 discussion moved

Anomie

New member
All that I said was that the initial 28 day trial is complete and it is since it began at the beginning of march. I looked at the clinical trials website and saw August, 2013 and thought that was this summer. Sorry it was late and I was tired but I'm sure they'll have some kind of statement on vx 661 as we get closer to the annual conference.

Why don't you try checking your tone before you go off snapping at everyone on here!
 

Anomie

New member
All that I said was that the initial 28 day trial is complete and it is since it began at the beginning of march. I looked at the clinical trials website and saw August, 2013 and thought that was this summer. Sorry it was late and I was tired but I'm sure they'll have some kind of statement on vx 661 as we get closer to the annual conference.

Why don't you try checking your tone before you go off snapping at everyone on here!
 

Incomudrox

New member
I didn't read every comment in here, but no one can claim their information is any accurate than anyone else's. Its all a matter of opinion and if someone else agrees with someone else then to you it will appear right in that person's eyes.. If anyone wants to start or continue an argument I can lock this thread so that no one can be a keyboard warrior. No hostility healthy debate however is fine.
 

Incomudrox

New member
I didn't read every comment in here, but no one can claim their information is any accurate than anyone else's. Its all a matter of opinion and if someone else agrees with someone else then to you it will appear right in that person's eyes.. If anyone wants to start or continue an argument I can lock this thread so that no one can be a keyboard warrior. No hostility healthy debate however is fine.
 

LouLou

New member
<div class="FTQUOTE"><begin quote><em>Originally posted by: <strong>Anomie</strong></em> Yeah, they don't want their investors to see what people are saying about the new drugs until they've verified everything and are ready to release a statement.</end quote>
BINGO!
And as Harriett mentioned it can jepeordize a trial because it can dilute the data by altering people's ACCURATE portayal of results based on what one participant hears another participant say. Additionally it could unblind aparticipant as it could give them the feeling that they know without a shadow of a doubt whether or not they are on drug or not and for this they are unblinded and can be asked to leave the study. Delays like this will delay the trial finish date.
 

LouLou

New member
<div class="FTQUOTE"><begin quote><em>Originally posted by: <strong>Anomie</strong></em> Yeah, they don't want their investors to see what people are saying about the new drugs until they've verified everything and are ready to release a statement.</end quote>
BINGO!
And as Harriett mentioned it can jepeordize a trial because it can dilute the data by altering people's ACCURATE portayal of results based on what one participant hears another participant say. Additionally it could unblind aparticipant as it could give them the feeling that they know without a shadow of a doubt whether or not they are on drug or not and for this they are unblinded and can be asked to leave the study. Delays like this will delay the trial finish date.
 

Anomie

New member
Its just that Harriet had already corrected my mistake and I didn't appreciate that passive-agressive comment about giving inacurate info and verifying my facts before I post just because I got one little date screwed up. Its like when someone says something snobby about you to someone else but loud enough so that you can hear it.
 

Anomie

New member
Its just that Harriet had already corrected my mistake and I didn't appreciate that passive-agressive comment about giving inacurate info and verifying my facts before I post just because I got one little date screwed up. Its like when someone says something snobby about you to someone else but loud enough so that you can hear it.
 

hmw

New member
Something I found really surprising- as well as frustrating- was also part of the presentation by our center director the other day. He mentioned that the recruitment process for one of the recent trials took a YEAR and they were only looking for a couple hundred people. Now- I don't think think it was one of the g551d trials, in which case due to the limited population that would qualify, it make more sense that it would take more time to find enough people to participate. Lauren? We're you there for this presentation by Dr. L to remember which trial he was referring to?

Anyway- if recruitment didn't take so long, imagine how much faster these phase 2's could be finished- everyone could start and finish right in the initial months of the trial beginning rather than it taking a year+ just to finish the part where people are actually taking the meds.

Thoughts about WHY this happens? Are centers not being proactive in encouraging their patients to participate or getting involved in the trial process themselves? What is the mindset of more of the patients out there? We all want more treatments and this is the only way to get them.
 

hmw

New member
Something I found really surprising- as well as frustrating- was also part of the presentation by our center director the other day. He mentioned that the recruitment process for one of the recent trials took a YEAR and they were only looking for a couple hundred people. Now- I don't think think it was one of the g551d trials, in which case due to the limited population that would qualify, it make more sense that it would take more time to find enough people to participate. Lauren? We're you there for this presentation by Dr. L to remember which trial he was referring to?

Anyway- if recruitment didn't take so long, imagine how much faster these phase 2's could be finished- everyone could start and finish right in the initial months of the trial beginning rather than it taking a year+ just to finish the part where people are actually taking the meds.

Thoughts about WHY this happens? Are centers not being proactive in encouraging their patients to participate or getting involved in the trial process themselves? What is the mindset of more of the patients out there? We all want more treatments and this is the only way to get them.
 

ashleydog

New member
recruitment for any clinical trial can take a long time. They are trying to use a patient population that is as similar as possible. So patients would need not only the same genotype, but there is generally a specified FEV1 range. Other medications that may either interact with the test medication or affect the results have to be ruled out. a patients history needs to be somewhat stable to prove that the new med is responsible for any improvement or decline. Different trials have different requirements. I was in an inhaled antibiotic trial where the requirements were so defined it took the team months to find participants, even though many people came to be screened for it.

In addition to all that, the vertex trials are very time intensive. Since it is an 18 and older trial, many adults may have trouble fitting it into thier schedule.

All that being said, I think all clinical trials are incredibly valuable and one of the reasons I am as old as I am (37) and doing as well as I am. I would rework my schedule to participate in as much research as I can.

one other reason recruitment may take a while, is that both the centers involved and the drug companies want to be sure there are no mistakes or issues. When a drug is first introduced to the CF population, it needs to be done slowly, until the relative saftey of the drug is more well known. You wouldn't want to take an unproven drug and give it to a large population all at once, if there were bad consequences they would have just been multiplied.

hope that helps, and THIS IS ALL SPECULATION I don't have any inside information that I am basing any thing on, just my own experience fom life and my job.
 

ashleydog

New member
recruitment for any clinical trial can take a long time. They are trying to use a patient population that is as similar as possible. So patients would need not only the same genotype, but there is generally a specified FEV1 range. Other medications that may either interact with the test medication or affect the results have to be ruled out. a patients history needs to be somewhat stable to prove that the new med is responsible for any improvement or decline. Different trials have different requirements. I was in an inhaled antibiotic trial where the requirements were so defined it took the team months to find participants, even though many people came to be screened for it.

In addition to all that, the vertex trials are very time intensive. Since it is an 18 and older trial, many adults may have trouble fitting it into thier schedule.

All that being said, I think all clinical trials are incredibly valuable and one of the reasons I am as old as I am (37) and doing as well as I am. I would rework my schedule to participate in as much research as I can.

one other reason recruitment may take a while, is that both the centers involved and the drug companies want to be sure there are no mistakes or issues. When a drug is first introduced to the CF population, it needs to be done slowly, until the relative saftey of the drug is more well known. You wouldn't want to take an unproven drug and give it to a large population all at once, if there were bad consequences they would have just been multiplied.

hope that helps, and THIS IS ALL SPECULATION I don't have any inside information that I am basing any thing on, just my own experience fom life and my job.
 

hmw

New member
Those are all excellent points. I really hadn't thought of the implications of giving a phase 2 med to all the trial participants all at once and what could happen if the med did not prove safe or well tolerated. Starting with fewer at a time and collecting data as you go- even though the waiting is hard! does give the information in a safer way.

I didn't get the impression you were trying to give any kind of inside information at all. :) It's just common sense based on how the trial process works. I took more time to read carefully through the allowing/excluding criteria for some of the trials I am particularly interested in on the clinicaltrials.gov site and you are right, it takes a lot of factors to line up just right.
 

hmw

New member
Those are all excellent points. I really hadn't thought of the implications of giving a phase 2 med to all the trial participants all at once and what could happen if the med did not prove safe or well tolerated. Starting with fewer at a time and collecting data as you go- even though the waiting is hard! does give the information in a safer way.

I didn't get the impression you were trying to give any kind of inside information at all. :) It's just common sense based on how the trial process works. I took more time to read carefully through the allowing/excluding criteria for some of the trials I am particularly interested in on the clinicaltrials.gov site and you are right, it takes a lot of factors to line up just right.
 
C

cindylou

Guest
I think the requirements of the trial make it hard for a lot of people to enter. I know I was offered the chance to do the original phase 3 Kalydeco trial, and really wanted to, but you have to be antibiotic-free for several weeks beforehand AND give up hypertonic saline. I felt like, at the time, my health was unstable enough that I wasn't comfortable giving up one of my "powerhouse meds" (hypertonic) and risking the chance of a placebo. I am getting ready to start Kalydeco later this week (yay!) and I just barely got off the phone with a study coordinator after we decided that I won't qualify for the Kalydeco data-collecting study, either... because I got out of the hospital too recently.

So yep, it's definitely tough to meet all the criteria!
 
C

cindylou

Guest
I think the requirements of the trial make it hard for a lot of people to enter. I know I was offered the chance to do the original phase 3 Kalydeco trial, and really wanted to, but you have to be antibiotic-free for several weeks beforehand AND give up hypertonic saline. I felt like, at the time, my health was unstable enough that I wasn't comfortable giving up one of my "powerhouse meds" (hypertonic) and risking the chance of a placebo. I am getting ready to start Kalydeco later this week (yay!) and I just barely got off the phone with a study coordinator after we decided that I won't qualify for the Kalydeco data-collecting study, either... because I got out of the hospital too recently.

So yep, it's definitely tough to meet all the criteria!
 
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